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Modafinil

Phase 3

Prostatic Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Sep 26, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

Modafinil · 1 trial · 2 indications

Phase 3 1
NCT00917748Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)Prostatic Neoplasms
COMPLETED84 Analytics
PHASE3COMPLETED
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
Prostatic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Fatigue scores daily assessed using the 11-point (0-10) 0 is the lower score and 10 is the highest. this score is calculated using the MD Anderson Symptom Inventory
From baseline to the end of study (week 12)

Secondary Endpoints

Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey
From baseline to the end of study (week 12)
Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire
At screening and from visit 6 (week 3) of treatment to end of study (week 12)
Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire
At baseline and from visit 6 (week 3) to end of study (week 12)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALdocetaxel chemotherapy + modafinil 100 mg capsules
2PLACEBO_COMPARATORdocetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)

Interventions

NameTypeDescription
DOCETAXEL(XRP6976) + MODAFINILDRUGarm 1: best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily arm 2: best supportive care (docetaxel chemotherapy) plus placebo of modafinil 200mg mane daily
ModafinilDRUGbest supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
Placebo of ModafinilDRUGBest supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2 * Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based che...

Countries:Australia
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Frequently asked questions about Modafinil

What is Modafinil used for in prostatic neoplasms?

Modafinil is being studied for use in prostatic neoplasms, specifically in patients treated with docetaxel-based chemotherapy for metastatic prostate cancer. It is an investigational small molecule in Phase 3 clinical development for this oncology indication, though it is not yet approved for this use.

Who makes Modafinil?

Modafinil is being developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical research on this small molecule for oncology applications, including its potential use in patients with prostatic neoplasms.

What phase is Modafinil in?

Modafinil is in Phase 3 clinical development for prostatic neoplasms. The drug is investigational and has not been approved for this indication. A Phase 3 study has been completed, but the drug remains in clinical development.

What clinical trials is Modafinil in?

Modafinil has one completed Phase 3 clinical trial, identified as NCT00917748, titled "Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)." This randomized, double-blind, placebo-controlled trial enrolled 84 participants and was conducted in Australia.

Is Modafinil the same as Provigil?

Modafinil is the generic name for the drug also known as Provigil. In the context of prostatic neoplasms, it is being investigated as an adjunct to docetaxel-based chemotherapy, though it is not approved for this oncology use.