A randomised, placebo-controlled, rising-dose crossover study to evaluate the effectiveness of modafinil in the management of fatigue in fibromyalgia - Modafinil and fibromyalgia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002209-22-GB

Enrollment

Registered

2005-07-27

Start date

2005-09-23

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Interventions

Trade Name: Provigil Product Name: Modafinil Product Code: CEP-1538 Pharmaceutical Form: Tablet INN or Proposed INN: Modafinil Current Sponsor code: CEP-1538 Concentration unit: mg milligram(s) Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written Informed Consent Widespread body pain A positive tender point count of at least 11 out of 18 points on digital palpation Daily fatigue of greater than 4 points on the Fatigue Scale Fatigue for greater than 24 hours following minimal activity Age 18 to 65 years inclusive Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of inflammatory disease or neoplasm Major psychological disorders known to affect sleep as assessed by the PRIME-MD scale. Pregnancy Breast feeding mothers Hypertension Patients with a score of less than 24 out of 30 on the Mini-Mental State Exam. Any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) Arrhythmia History of left ventricular hypertrophy, cor pulmonale or mitral valve prolapse Lactose intolerance Known sensitivity to other constituents of modafinil tablet ie maize starch, magnesium silicate, croscarmellose sodium, Povidone K90, Talc or magnesium stearate. Patient is taking anticonvulsants, anticoagulants, melatonin, St John’s Wort, methylphenidate, amphetamines, pemoline, zolpidem, monoamine oxidase inhibitors, barbiturates, benzodiazepines, lithium or antipsychotic drugs. Has a significant deviation from normal in the physical examination. Has any disorder that may interfere with drug absorption, distribution, metabolism or excretion (including gastro-intestinal surgery). Any other sleep disorder including obstructive sleep apnoea, narcolepsy or periodic leg movement syndrome. Previous use of Modafinil (Provigil). Clinical history of heart, kidney or liver disease, heart attack, diseases of the CNS, alcoholism or drug dependence.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether Modafinil is more effective than placebo in reducing subjective fatigue as measured by the Brief Fatigue Inventory.;Secondary Objective: To determine whether Modafinil is more effective than placebo in reducing daytime sleepiness, sleep duration or pain; or improving cognitive function testing, sleep quality or physical health and vitality scores. ;Primary end point(s): The number of patients with a significant change on the Brief Fatigue Inventory following treatment with Modafinil compared to placebo.	—

Measure

Time frame

Main Objective: To determine whether Modafinil is more effective than placebo in reducing subjective fatigue as measured by the Brief Fatigue Inventory.;Secondary Objective: To determine whether Modafinil is more effective than placebo in reducing daytime sleepiness, sleep duration or pain; or improving cognitive function testing, sleep quality or physical health and vitality scores. ;Primary end point(s): The number of patients with a significant change on the Brief Fatigue Inventory following treatment with Modafinil compared to placebo.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026