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Hyper- and Hypokalemic Periodic Paralysis Study

NCT00494507 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-06-14

Study results available
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Summary

The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis.

Conditions

  • Hyperkalemic Periodic Paralysis
  • Hypokalemic Periodic Paralysis

Interventions

DRUG

Dichlorphenamide (double-blind)

50mg tablet; maximum dosage 400mg/day

DRUG

Placebo (double-blind)

Inactive substance manufactured to look like Dichlorphenamide 50mg tablet

DRUG

Dichlorphenamide (open-label)

50mg tablet; maximum dosage 400mg/day

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • Robert C. Griggs, M.D. · University of Rochester

  • Rabi Tawil, M.D. · Co-Principal Investigator, University of Rochester

  • Michael McDermott, Ph.D. · Biostatistician, University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • United States
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00494507 on ClinicalTrials.gov