scholarly journals Long‐term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open‐label extension trial

Epilepsia ◽  
2021 ◽  
Author(s):  
Elizabeth A. Thiele ◽  
E. Martina Bebin ◽  
Francis Filloux ◽  
Patrick Kwan ◽  
Rachael Loftus ◽  
...  
Keyword(s):  
Tuberous Sclerosis ◽  
Tuberous Sclerosis Complex ◽  
Open Label ◽  
Open Label Extension ◽  
Extension Trial

Long-Term Safety, Efficacy of Add-on Cannabidiol (CBD) for Treatment of Tuberous Sclerosis Complex-Associated Seizures in an Open-Label Extension

2021 ◽  
Author(s):  
F. Sahebkar ◽  
E. M. Bebin ◽  
F. Filloux ◽  
F. E. Jansen ◽  
P. Kwan ◽  
...  
Keyword(s):  
Tuberous Sclerosis ◽  
Tuberous Sclerosis Complex ◽  
Open Label ◽  
Open Label Extension

Continuous Weekly Adalimumab is the Optimal Long-Term Strategy for Patients with Moderate-to-Severe Hidradenitis Suppurativa: Results from the PIONEER Open Label Extension Trial

2017 ◽  
Vol 1 ◽  
pp. s129
Author(s):  
Alexa B Kimball ◽  
Martin M Okun ◽  
Gerit Mulder
Keyword(s):  
Hidradenitis Suppurativa ◽  
Open Label ◽  
Open Label Extension ◽  
Extension Trial

Abstract Not Available Disclosures: Study supported by AbbVie.

scholarly journals Long‐term safety and efficacy of add‐on cannabidiol in patients with Lennox–Gastaut syndrome: Results of a long‐term open‐label extension trial

Epilepsia ◽  
2021 ◽  
Author(s):  
Anup D. Patel ◽  
Maria Mazurkiewicz‐Bełdzińska ◽  
Richard F. Chin ◽  
Antonio Gil‐Nagel ◽  
Boudewijn Gunning ◽  
...  
Keyword(s):  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Extension ◽  
Extension Trial

scholarly journals Long-Term Safety and Efficacy of Risankizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Results from a Phase 2 Open-Label Extension Trial

2021 ◽  
Author(s):  
Kim A. Papp ◽  
Saskia de Vente ◽  
Jiewei Zeng ◽  
Mary Flack ◽  
Byron Padilla ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Phase 2 ◽  
Chronic Plaque Psoriasis ◽  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Extension ◽  
Extension Trial

Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial

CNS Spectrums ◽  
2013 ◽  
Vol 18 (1) ◽  
pp. 43-54 ◽  
Author(s):  
Andrew J. Cutler ◽  
Amir H. Kalali ◽  
Greg W. Mattingly ◽  
Jelena Kunovac ◽  
Xiangyi Meng
Keyword(s):  
Serum Glucose ◽  
Favorable Effect ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Once Daily ◽  
Syndrome Scale ◽  
Open Label Extension ◽  
Negative Syndrome ◽  
Extension Trial

Introduction/ObjectiveLong-term use of the atypical antipsychotic iloperidone has not been investigated at doses above 16 mg/d. This article describes safety and tolerability results from the 25-week open-label extension of a 4-week placebo- and ziprasidone-controlled clinical trial of iloperidone.MethodsPatients received a dose of 24 mg/d (given as 12 mg twice daily; mean dose = 21.6 mg) that could be reduced to 12 mg/d (given once daily at bedtime) any time after day 35 at the investigator's discretion.ResultsA total of 72/173 patients (41.6%) completed the open-label extension. Treatment-emergent adverse events (TEAEs), most mild to moderate in severity, included headache (13.9%), weight increase (9.2%), dizziness (6.9%), nausea (6.4%), sedation (6.4%), and insomnia (5.2%). The only notable dose-related TEAEs were increased weight and headache. Levels of serum glucose, lipids, and prolactin were essentially unchanged or decreased during treatment. In general, akathisia and extrapyramidal symptoms (EPS) improved or were unchanged during treatment. There was no signal of worsening of efficacy based on changes from baseline in the Positive and Negative Syndrome Scale-Total.Discussion/ConclusionThis study further supports the long-term safety and tolerability of iloperidone for the treatment of schizophrenia, including iloperidone's favorable effect on metabolic laboratory parameters and low propensity to cause akathisia or EPS.

scholarly journals Long-Term Exposure and Safety of a Novel Topical Rapamycin Cream for the Treatment of Facial Angiofibromas in Tuberous Sclerosis Complex: Results From a Single-Center, Open-Label Trial

2019 ◽  
Vol 6 ◽  
pp. 2329048X1983504
Author(s):  
Margaret C. Wheless ◽  
Apana A. Takwi ◽  
Hassan Almoazen ◽  
James W. Wheless
Keyword(s):  
Tuberous Sclerosis ◽  
Tuberous Sclerosis Complex ◽  
Fibrous Tissue ◽  
Systemic Absorption ◽  
Topical Formulation ◽  
Open Label ◽  
Long Term Follow Up ◽  
The Face ◽  
Systemic Side Effects

Facial angiofibromas, composed of fibrous tissue and blood vessels appearing on the face, are closely associated with tuberous sclerosis complex. Historically, oral rapamycin, a mammalian target of the rapamycin inhibitor of cell proliferation, has been used to treat visceral tuberous sclerosis–related tumors; however, the side effect profile of this medicine generally precludes its use in patients lacking significant internal involvement. The authors developed a novel topical formulation of rapamycin cream to treat the facial angiofibroma without exposing patients to possible systemic side effects. We followed 11 patients in a long-term, open-label, prospective study to evaluate the safety and effectiveness of rapamycin cream when used chronically. All of the patients showed an improvement in the appearance of their facial angiofibroma which was maintained in long-term follow-up without safety concerns or systemic absorption. The novel rapamycin cream was tolerated well by all patients and represents a way to address the cutaneous manifestation of tuberous sclerosis complex.

Long-term safety of an extended-cycle oral contraceptive (Seasonale): A 2-year multicenter open-label extension trial

2006 ◽  
Vol 195 (1) ◽  
pp. 92-96 ◽  
Author(s):  
F.D. Anderson ◽  
William Gibbons ◽  
David Portman
Keyword(s):  
Oral Contraceptive ◽  
Open Label ◽  
Open Label Extension ◽  
Extended Cycle ◽  
Extension Trial

Long-Term Safety, Tolerability, and Clinical Efficacy of Quetiapine in Adolescents: An Open-Label Extension Trial

2003 ◽  
Vol 13 (1) ◽  
pp. 75-82 ◽  
Author(s):  
Brian McConville ◽  
Lynn Carrero ◽  
Dennis Sweitzer ◽  
Larry Potter ◽  
Robert Chaney ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Open Label ◽  
Open Label Extension ◽  
Extension Trial
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