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Trial · NCT01950234

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProportion of Patients Exhibiting a 20% Worsening in T25FW at 36 MonthsMonth 36
SecondarySafety and Tolerability of ACTH: Menstrual Changes [Female]Month 36Count of participants self reporting at any time throuhgout the study noticing any changes in menstrual cycle or period.
SecondarySafety and Tolerability of ACTH: DEXA ScansMonth 36
The number is a T-score. There is no maximum or minimum value. Mean change in average of 5 DEXA scan values dual-energy x-ray absorptiometry; measures bone mineral density. Higher numbers are better. A DEXA T-score has a mean of 0 and standard deviation of 1, meaning that a T-score represents how many standard deviations a person's bone density is away from the average bone density of a healthy young adult, with a score of 0 indicating average bone density. Higher scores are better, indicating better bone density. A T-score of -1 to +1 is considered normal bone density, a score between -1 and -2.5 indicates osteopenia (low bone mass), and a score of -2.5 or lower indicates osteoporosis.
SecondarySafety and Tolerability of ACTH: BruisingMonth 36Count of participants self reporting at any time throuhgout the study that they bruise more easily
SecondarySafety and Tolerability of ACTH: Swelling AnklesMonth 36Count of participants self reporting at any time throuhgout the study that have noticed swelling in their ankles
SecondarySafety and Tolerability of ACTH: Hair LossMonth 36Count of participants self reporting at any time throuhgout the study that have noticed losing more hair
SecondarySafety and Tolerability of ACTH: AcneMonth 36Count of participants self reporting at any time throuhgout the study that have noticed in increase in acne
SecondarySafety and Tolerability of ACTH: InsomniaMonth 36Count of participants self reporting at any time throuhgout the study that they have been having trouble sleeping
SecondarySafety and Tolerability of ACTH: Mood ChangeMonth 36Count of participants self reporting at any time throuhgout the study that they have noticed changes in mood
SecondarySafety and Tolerability of ACTH: GI UpsetMonth 36Count of participants self reporting at any time throuhgout the study that they have had upset stomach, indigestion, diarrhea, or bloating
SecondarySafety and Tolerability of ACTH: FatigueMonth 36Count of participants self reporting at any time throuhgout the study that noticed feeling tired or worn out
SecondarySafety and Tolerability of ACTH: Unpleasant TasteMonth 36Count of participants self reporting at any time throuhgout the study noticing a metallic taste in their mouth
SecondarySafety and Tolerability of ACTH: Blurred VisionMonth 36Count of participants self reporting at any time throuhgout the study noticing any blurred vision
SecondarySafety and Tolerability of ACTH: Moon FaciesMonth 36New physician assessed moon facies over study duration
SecondarySafety and Tolerability of ACTH: Skin ThinningMonth 36New physician assessed skin thinning over study duration
SecondarySafety and Tolerability of ACTH: HirsuitismMonth 36New physician assessed hirsuitism over study duration
SecondarySafety and Tolerability of ACTH: BruisingMonth 36New physician assessed bruising over study duration
SecondarySafety and Tolerability of ACTH: Ankle SwellingMonth 36New physician assessed ankle swelling over study duration
SecondarySafety and Tolerability of ACTH: Hair LossMonth 36Any new physician assessed hair loss over study duration
SecondarySafety and Tolerability of ACTH: CataractsMonth 36New physician assessed cataracts over study duration

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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